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The FDA has classified Abilify as a pregnancy Category C medicine, meaning that a pregnant woman may take it if her healthcare provider believes that its benefits outweigh the possible risks to her unborn child. In animal studies, the medication caused birth defects and miscarriages when it was given to pregnant rats. If you become pregnant while taking Abilify, talk to your healthcare provider.

Is Abilify Safe During Pregnancy?

Abilify® (aripiprazole) may not be safe for women who are pregnant. In previous animal studies that looked at the effects of Abilify during pregnancy, Abilify increased the chances of miscarriage and birth defects.

Abilify and Pregnancy Category C

The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
When given to pregnant rats, Abilify caused low birth weight, slow development, and undescended testicles. Also, the female offspring were less fertile that normal. Abilify also caused miscarriages and skeletal birth defects.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn child.
There have reports of side effects or withdrawal symptoms in newborns whose mothers took antipsychotic medications (such as Abilify) during the third trimester. Such problems included:
  • Agitation
  • Still muscles
  • Weak muscle tone
  • Shakiness
  • Excessive drowsiness
  • Breathing difficulty
  • Feeding problems.
In some cases, these problems were mild and temporary. Some cases, however, were serious and required prolonged stays in the neonatal intensive care units.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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